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DePuy Inc. (NYSE:DPU) has received Premarket Approval (PMA) from the U.S. Food and Drug Administration to market "Endurance" bone cement in the United States, according to Mike Dormer, president and chief executive officer of DePuy.
Dormer said the approval allows DePuy to begin marketing Endurance immediately in the estimated $60 million market for bone cement in the United States. Bone cement is a grout made of polymethylmethacrylate and is used by orthopedic surgeons to fix joint reconstructive implants, primarily hips and knees, in the replacement of worn or damaged joints.
He said DePuy's entry into the U.S. bone cement market follows its 1994 acquisition of U.K.-based CMW Laboratories, the world's most experienced manufacturer of bone cement. Following the acquisition, DePuy gained premarket approval to market CMW I bone cement in the United States early this year and filed a PMA application related to Endurance shortly after.
